Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout

A Phase 2, Randomized, Open-Label, Allopurinol-Controlled, Multicenter Study With Two Optional Extensions to Evaluate the Safety and Efficacy of AR882 Alone or in Combination With Allopurinol in Tophaceous Gout Patients

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05253833

Enrollment

Registered

2022-02-24

Start date

2022-08-12

Completion date

2024-10-28

Last updated

2025-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arthritis, Gouty, Gout, Gout Chronic, Hyperuricemia

Brief summary

This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.

Interventions

DRUGAR882 Dose 1

Solid Oral Capsule

DRUGAR882 Dose 2

Solid Oral Capsule

DRUGAllopurinol Tablet

Solid tablet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* History of gout * at least 1 measurable tophus on the hands/wrists and/or feet/ankles ≥ 5 mm and ≤ 30 mm in the longest diameter. * Patients who are NOT on approved ULT must have sUA \> 7 mg/dL * Patients who are on medically appropriate ULT must have sUA \> 6 mg/dL * Estimated Glomerular Filtration Rate (eGFR) ≥ 45 mL/min/1.73m2

Exclusion criteria

* Malignancy within 5 years, except for successfully treated basal or squamous cell carcinoma of the skin * Pregnant or breastfeeding * History of kidney stones

Design outcomes

Primary

Measure	Time frame	Description
Serum urate (uric acid) (sUA) level < 5 mg/dL at month 3	12 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \< 5 mg/dL at month 3

Secondary

Measure	Time frame	Description
Change from baseline in tophus area at Months 3 and 6	12 weeks and 24 weeks	Comparison of the treatment groups for tophus area as measured by digital calipers
Change from baseline in tophus crystal volume at Months 6	24 weeks	Comparison of the treatment groups for tophus crystal as measured by Dual-energy computerized tomography.
Serum urate (uric acid) (sUA) level <6, <4 and <3 mg/dL at month 3	12 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \<6, \<4 and \<3 mg/dL at month 3
Serum urate (uric acid) (sUA) level <6, < 5, <4 and <3 mg/dL at month 6	24 weeks	Comparison of the treatment groups for the proportion of patients with serum urate (uric acid) (sUA) level \<6, \< 5, \<4 and \<3 mg/dL at month 6
Incidence of Adverse Events	24 weeks	Treatment Emergent Adverse Events and Serious Adverse Event incidence.

Countries

New Zealand, Taiwan, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026